Kornimate/medical-research-clean huggingface dataset:
mini- or less-open sublay operation (milos) of incisional hernias

Conditions: Incisional Hernia

Summary: prospective non-randomized observational register study of all elective symptomatic incisional hernias operated on in the hernia center of reference of gross sand hospital using the novel endoscopic assisted mini- or less-open sublay technique. the data of all patients were prospectively documented in the german hernia registry "herniamed". the novel milos-technique allows the minimal invasive implantation of large extraperitoneal meshes for the treatment of primary and secondary incisional hernias.

prospective non-randomized observational register study of all elective symptomatic incisional hernias operated on in the reference hernia center of gross sand hospital between 1 january 2010 and 30 september 2015 using the novel endoscopic assisted mini- or less-open sublay technique. the novel milos-technique allows the minimal invasive implantation of large extraperitoneal meshes for the treatment of primary and secondary incisional hernias.the data of all patients were prospectively documented in the german hernia registry "herniamed". data privacy protection was strictly implemented according to german federal law. all patients were informed in detail about the new surgical technique, other treatment options, prospective register study with one year questionnaire follow-up, data documentation. all patients gave written consent. a propensity score matching of all patients of the milos-cohort of gross sand hospital with patients with comparable incisional hernias who were operated on using the laparoscopic intraperitoneal onlay mesh (ipom) technique or open sublay technique in other institutions participating in the german hernia database "herniated" was performed.

Eligibility criteria:
inclusion criteria: * all patients with symptomatic elective primary or secondary incisional hernias: * median incisional hernias * lateral incisional hernias exclusion criteria: * emergencies * very large incisional hernias that required incisions larger than 12 cm

Keywords: recurrent abdominal wall hernia incisional hernia
intravenous and topical analgesics for procedural pain in neonates

Conditions: Pain; Infant, Newborn

Summary: this study will test which type of pain medication is best for the management of pain in newborn preterm and full-term infants having a deep intravenous cannula inserted. it will compare the effectiveness of intravenous morphine alone, a local anaesthetic cream (amethocaine) alone, and both medications together. it will also determine the safety of both medications.


Eligibility criteria:
inclusion criteria: * preterm and full-term infants in the nicu requiring a percutaneous central venous catheter * ventilatory support in the form of conventional ventilation, continuous positive air pressure (cpap) or high frequency oscillation(hfo) exclusion criteria: * seizures * receiving muscle relaxants * skin disorders causing disruption of stratum corneum

Keywords: pain analgesia morphine amethocaine neonate
observation of the result after chondron (autologous chondrocytes) treatment

Conditions: Articular Cartilage Defects of Knee

Summary: this investigator-sponsored trial attempts to evaluate the effectiveness of chondron transplantation by tracking subjects who had the chondron implantation to observe effectiveness.

many treatment cases proved that autologous chondrocyte transplantation is a useful treatment method for patients with damaged articular cartilage. this investigator-sponsored trial attempts to evaluate the effectiveness of chondron(autologous chondrocyte) transplantation by tracking subjects who had the chondron implantation to observe effectiveness.

Eligibility criteria:
* inclusion criteria: 1. adult males and females aged between 15 and 65 2. patients with a partial cartilaginous defect in the ankle joint confirmed arthroscopically or visually 3. patients with misalignment between tibia and talus of the ankle joint, lateral ankle instability, and a bony defect in the cartilaginous defect or who had a correction simultaneously or in advance 4. patients whose surrounding cartilage is normal 5. subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial * exclusion criteria: 1. patients hypersensitive to bovine protein 2. patients hypersensitive to antibiotics like gentamicin 3. patients with inflammatory arthritis, such as rheumatoid arthritis and gouty arthritis 4. patients with arthritis associated with autoimmune diseases 5. patients who are pregnant, nursing a baby or likely to get pregnant 6. patients with other diseases including tumors except for cartilaginous defects of joints 7. patients with an anamnesis within the past two years, such as radiation treatment and chemotherapy 8. diabetics (however, patients who were normal in the blood glucose test and have no complication due to diabetes will be excluded if the doctor says chondron can be administered to them) 9. patients with infections who are taking antibiotics and antimicrobial agents 10. patients who are treated with adrenal cortical hormones 11. patients whom the investigators find to be unfit for this clinical trial, such as mental patients

Keywords: articular cartilage defects aci autologous chondrocyte implantation knee joint chondron
the efficacy of periarticular single drug compared with multimodal drug injection in controlling pain after tka

Conditions: Postoperative Pain

Summary: the purpose of this study is to determine the periarticular multimodal drug injection has more efficacy for controlling pain after tka than single anaesthetic drug injection.

many studies have to determine the efficacy of periarticular multimodal drug injection or single local anaesthetic drug comparing with placebo for pain controlled in tka. but in this study would like to determine which one of both drugs are more efficacy. in multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine while single anaesthetic drug has levobupivacaine and epinephrine.

Eligibility criteria:
inclusion criteria: * primary osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty * age 50-85 years old exclusion criteria: * unable to perform spinal anaesthesia * history of drug allergies; local anaesthesia, non-steroidal anti-inflammatory drugs, morphine, epinephrine * cognitive function impairment * renal impairment (creatinine clearance \< 30 ml/min) * liver impairment, gastrointestinal bleeding

Keywords: pain control periarticular injection total knee arthroplasty levobupivacaine multimodal drug injection
phase 1/2 trial of gavo-cel (tc-210) in patients with advanced mesothelin-expressing cancer

Conditions: Mesothelioma; Mesothelioma, Malignant; Mesothelioma; Pleura; Mesotheliomas Pleural; Mesothelioma Peritoneum; Cholangiocarcinoma; Cholangiocarcinoma Recurrent; Ovarian Cancer; Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Metastatic; High Grade Ovarian Serous Adenocarcinoma

Summary: gavocabtagene autoleucel (gavo-cel; tc-210) is a novel cell therapy that consists of autologous genetically engineered t cells expressing a single-domain antibody that recognizes human mesothelin, fused to the cd3-epsilon subunit which, upon expression, is incorporated into the endogenous t cell receptor (tcr) complex. this phase 1/2 study aims to establish the recommended phase 2 dose (rp2d) and subsequently evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary phase 2 endpoints.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age at the time the informed consent is signed. * patient has a pathologically confirmed diagnosis of either malignant pleural/peritoneal mesothelioma (mpm), serous ovarian adenocarcinoma, cholangiocarcinoma, or non-small cell lung cancer (nsclc) at screening. * patient's tumor has been pathologically reviewed by the central laboratory. for serous ovarian adenocarcinoma, patients must have confirmed positive msln expression on \>/= 30% of tumor cells that are 1+, 2+, and/or 3+ by immunohistochemistry (ihc). ovarian patients will subsequently be stratified into two groups: high msln expression (\>/= 50% of tumor cells that are 2+ and/or 3+) or low msln expression (\>/= 30% of tumor cells that are 1+, 2+, and/or 3+ not meeting criteria for the high msln expression group). mpm patients must have msln expression of \>/= 50% of tumor cells that are 2+ and/or 3+ by ihc. cholangiocarcinoma and nsclc patients must have msln expression of \>/= 30% of tumor cells that are 1+, 2+, and/or 3+ by ihc. * prior to gavo-cel infusion, patients must have received at least 1 systemic standard of care therapy for metastatic or unresectable disease, with the exception of cholangiocarcinoma patients who may have elected not to pursue standard frontline therapy. regardless of tumor type, patients must not exceed 5 prior lines of therapy (excluding bridging therapy and surgical procedures). more details provided in the clinical protocol. * patient has an eastern cooperative oncology group performance status 0 or 1. * patient has a left ventricular ejection fraction \> 45% as measured by resting echocardiogram, with no clinically significant pericardial effusion. * patient is fit for leukapheresis and has adequate venous access for the cell collection. * patient must have adequate organ function as indicated by the laboratory values in the clinical protocol
triage: triage of sepsis at emergency department

Conditions: Sepsis; Severe Sepsis

Summary: sepsis is a serious systemic disease defined as a combination of systemic inflammation response syndrome (sirs) plus a confirmed or suspected infection. untreated or inadequately treated cases can lead to severe sepsis or septic shock; being characterized by high mortality and morbidity. symptoms and signs of sepsis are variable and this makes clinical recognition and assessment very difficult in particular on emergency department (ed) patients due to their infectious illness background and the frequent comorbidities. also, the severity of the condition may not be apparent at initial contact with ed personnel: patients may arrive at ed with mild clinical manifestation and rapidly progress to critical illness, or rather at the opposite others have benign evolution despite a similar symptoms. in these conditions, the main challenge of ed clinicians is differentiating mild infections from life-threatening ones in the heavy workload of ed environment objective of triage project is to identify and validate biomarkers able to predict the clinical worsening of patients freshly admitted at emergency department. targeted population is adult patients freshly admitted at ed, whom blood samples will serve to validate candidate markers.


Eligibility criteria:
inclusion criteria: * male or female aged over 18 years * patient with a single acute infection site suspected or confirmed by the clinician on clinical or paraclinical manifestations. * patient admitted to ed with at least two systemic inflammatory response syndrome (sirs) criteria * patient with symptoms for less than 72 hours upon arrival to the emergency department. * patient requiring according to physician judgment of hospitalization for at least 48 hours for his septic episode * patient having been informed of the conditions of the study and having signed the informed consent form exclusion criteria: * patient arrived in an emergency room for over 6 hours. * patient with septic shock upon arrival to the ed patient with acute organ failure on arrival at emergencies other than septic. * patient hospitalized in the week before inclusion. * patient immunocompromised (hiv, transplanted, patients undergoing chemotherapy, patients receiving treatment\> 20 mg / day of prednisolone or equivalent). * patient with known pathology among non-infectious pathologies potentially associated with sirs * patient diagnosed with sepsis within 30 days before the date of inclusion. * patient has already been included in the study. * minor person. * person refusing to sign the written consent form. * pregnant woman parturient or nursing. * patient with no social security insurance, with restricted liberty or under legal protection

Keywords: sepsis severe sepsis infections worsening
chidamide with pet regimen for angioimmunoblastic t cell lymphoma (pet: prednisone, etoposide and thalidomide)

Conditions: Angioimmunoblastic T-cell Lymphoma

Summary: this study aims to investigate the efficacy and safety of pet regimen combined with chidamide for angioimmunoblastic t cell lymphoma patients.

patients enrolled in the trial would be given prednisone, etoposide, thalidomide and chidamide, and the response and side effects are observed and documented.

Eligibility criteria:
inclusion criteria: 1. pathologically diagnosed as angioimmunoblastic t cell lymphoma (diagnosed by pathologic department in iiia hospitals or verified by certified institutions), immunohistochemistry should include: cd3, cd4, cd8, cd20, cd10, cd21, cd35, bcl6, cxcl13, eber, pd-1, ki67. 2. at least on measurable focus (≥1.0\*1.0cm by imaging), or at least one evaluable focus; 3. age 18-75 years, both male and female; 4. ecog 0-2, kps≥ 70points; 5. expected survival ≥3 months; 6. peripheral blood neutrophil count ≥1.5×10\^9/l, platelet count≥ 75×10\^9/l, hb≥ 90g/l; 7. liver function: bilirubin ≤1.5 times of the normal maximum; ast、alt≤2 times of the normal maximum (for patients with liver infiltration ast、alt≤3 times of the normal maximum); renal function: blood creatinine ≤2 times the normal maximum; 8. negative random pregnancy test for fertile women patients within 7 days before enrollment; 9. no radiation therapy, chemotherapy, targeted therapy nor hemopoietic stem cell transplantation within 4 weeks before enrollment; 10. no anti-tumor therapy at enrollment, including herbal therapy, immunotherapy and biologic therapy, symptomatic treatment is not within this range; exclusion criteria: 1. women during pregnancy or lactation, and fertile women that are not willing to take contraceptive measurements; 2. patients with other malignant tumors simultaneously that have not been effectively controlled; 3. patients with history of using hdac inhibitors; 4. patients who are allergic to medicine used in the trial, or have metabolic disorders toward these medicine; 5. patients with severe active infection; 6. patients with hiv or syphilis infection; 7. patients with prolonged qt interval (male \> 450ms，female \> 470ms), or chronic heart failure patients with level iii or iv cardiac function; or those have the following heart disease within 6 months before enrollment: acute coronary syndrome, acute heart failure (heart function level iii or iv), distinctive ventricular arrhythmias (prolonged ventricular tachycardia, ventricular fibrillation, etc); 8. patients with history of organ transplantation; 9. patients with history of thrombosis and embolism; 10. patients with mental disorders or those who are unable to sign a written consent; 11. patients with drug abuse or long-time alcoholism that may influence the result of the trial; 12. patients who do not have capacity of legal transactions; 13. patients currently in other clinical trials; 14. those who are recognized as inappropriate for the trial by the investigators;
bioequivalence study of levetiracetam tablets, 750 mg of dr. reddy's under fed conditions

Conditions: Healthy

Summary: the purpose of this study is to compare the single-dose relative bioavailability study of levetiracetam tablets 750 mg with keppra® 750 mg tablets under fed conditions.

this is an open-label, randomized, single-dose 2-way crossover relative bioavailability study in healthy adult male volunteers under fed conditions with a washout period of 7 days.

Eligibility criteria:
inclusion criteria: * healthy adult male volunteers, 18 to 55 years of age; * weighing at least 60 kg and within 15% of their ideal weights (table of "desirable wights of adults", metropolitan life insurance company, 1983); * medically healthy subjects with clinically normal laboratory profiles and ecgs as deemed by the principal investigator; * voluntarily consent to participate in the study exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. * in addition, history or presence of: 1. alcoholism or drug abuse within the past 2 years; 2. hypersensitivity or idiosyncratic reaction to levetiracetam; * subjects who have been on an special diet (for whatever reason) during the 30 days prior to the first dose and throughout the study. * subjects who have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the first dose. * subjects who have made a plasma donation within 7 days prior to the first dose. * subjects who have participated in another clinical trial within 30 days prior to the first dose. * subjects with hemoglobin less than 12.0 g/dl. * subjects who have participated in another clinical trial within 30 days prior to the first dose.

Keywords: bioavailability crossover levetiracetam
a pk study to assess the drug-drug interaction of a bcrp inhibitor on adagrasib

Conditions: Healthy Adults

Summary: a phase 1, open-label, one-sequence crossover study to investigate the effect of a breast cancer resistance protein inhibitor on the single-dose pharmacokinetics of adagrasib in healthy adult subjects


Eligibility criteria:
inclusion criteria: 1. males or females, of any race, between 18 and 60 years of age, inclusive, at screening. 2. body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. 3. in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ecg, vital sign measurements, or clinical laboratory evaluations at screening and check-in as assessed by the investigator. 4. females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. females of childbearing potential must agree to use contraception. 5. male subjects must agree to use contraception. 6. able to comprehend and willing to sign an informed consent form (icf) and to abide by the study restrictions. exclusion criteria: 1. significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, thrombotic, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator. 2. history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the investigational product (ip), or other substance (not including seasonal allergies). 3. history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome). 4. significant history or clinical manifestation of any hepatic disease, as determined by laboratory abnormalities. 5. history or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study. 6. ventricular dysfunction or history of risk factors for torsades de pointes. 7. history of drug abuse within 2 years prior to screening. 8. history of alcohol abuse within 12 months prior to screening. 9. positive serology test results for hepatitis b surface antigen, hepatitis c antibody, and/or human immunodeficiency virus (hiv) 1/2. 10. use of tobacco- or nicotine-containing products within 3 months prior to check-in. 11. use of any drugs or substances known or suspected to alter drug absorption, distribution, metabolism, or elimination. 12. use or intend to use any prescription medications/products within 14 days prior to check-in. 13. use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations. 14. participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days. 15. subjects who, in the opinion of the investigator, should not participate in this study.
a phase ib/ii dose-finding study to assess the safety and efficacy of lde225 + inc424 in patients with mf

Conditions: Primary Myelofibrosis; Thrombocytosis; Essential Thrombocythemia; Polycythemia Vera; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Blood Coagulation Disorders; Blood Platelet Disorders; Hemorrhagic Disorders

Summary: the purpose of this phase ib/ii clinical trial was to: a) evaluate the safety of the co-administration of lde225 and inc424 in myelofibrosis patients and establish a maximum tolerated dose and/or recommended phase ii dose of the combination and b) to assess the efficacy of the co-administration of lde225 and inc424 on spleen volume reduction.

the study is considered to have been completed because the participants completed the study as per study design at the time of trial termination. if participants were already in extension phase until discontinuation criteria were met or alternative setting was available, they were considered as completed. the study was terminated due to one of the compounds being divested.

Eligibility criteria:
inclusion criteria: * diagnosed with pmf per 2008 who criteria, post-pv mf or post-et mf per iwg-mrt criteria. * ineligible or unwilling to undergo stem cell transplantion. * plt counts \> or = 75x 10\^9/l not reached with the aid of transfusions. * ecog performance status ≤ 2. * palpable splenomegaly defined as ≥ 5 cm below the left costal margin. * intermediate risk level 1 (1 prognostic factor which is not age), intermediate risk level 2, or high risk. * active symptoms of mf as demonstrated by one symptom score of at least 5 (0 to10 point scale) or two symptom scores of at least 3 (0 to 10 point scale) on the mf symptom assessment form (mfsaf). exclusion criteria: * previous therapy with jak or smoothened inhibitors. * patient is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg) and lmwh. * impairment of gi function or gi disease that may significantly alter the absorption of inc424 or lde225 (e.g., uncontrolled nausea, vomiting, diarrhea; malabsorption syndrome; small bowel resection). * splenic irradiation within 12 months prior to screening. * pregnant or nursing women. * wocbp not using highly effective methods of contraception * sexually active males who refuse condom use * patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as hmg coa inhibitors (statins), clofibrate and gemfibrozil. pravastatin may be used if necessary, with extra caution.

Keywords: dose escalation maximum tolerated dose mtd safety expansion safety efficacy myelofibrosis post-polycythemia vera myelofbrosis (post pv-pmf) post essential thrombocythemia myelofibrosis (post et-mf) primary myelofibrosis (pmf) intermediate risk myelofibrosis high risk myelofibrosis combination treatment hedgehog signaling pathway smoothened inhibitor jak inhibitor